A Study to Compare Two Different Sleep Tests in Participants With No Symptoms or Early Symptoms o… (NCT07485153) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Study to Compare Two Different Sleep Tests in Participants With No Symptoms or Early Symptoms of Alzheimer's Disease
Singapore35 participantsStarted 2026-03
Plain-language summary
The purpose of this study is to compare the results of two different sleep tests in Alzheimer's patients with no symptoms or early symptoms. Participants will undergo two simultaneous sleep tests (polysomnography) in a sleep laboratory for two nights and one sleep test at home for three nights. For each participant, the study will last at least a week and will last up to three months.
Who can participate
Age range
55 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Have mild cognitive impairment, subjective memory complaints, or normal cognition.
* Evidence of the presence of Alzheimer's pathology as measured by amyloid positron emission tomography (PET), cerebrospinal fluid biomarkers (amyloid beta and tau), or blood biomarkers.
* Montreal Cognitive Assessment (MoCA) score of 24 or greater.
* Clinical Dementia Rating Scale (CDR) global score of 0 or 0.5.
* Able to provide signed informed consent.
* On stable medications (including those for Alzheimer's disease) for 30 days before the first recording night of Study Period 1, and willing to remain on stable therapy during the study.
* Must have a study partner who knows the participant well and can accompany the participant at visits where informant-rated scales are administered.
Exclusion Criteria:
* Severe illness that in the investigator's judgement would adversely affect the participant's participation in the study.
* Skin illness that may interfere with study assessments.
* Has a pacemaker or implantable cardioverter defibrillator.
* Diagnosed with a sleep disorder.
* Has irregular circadian patterns (works night shifts, etc.).
* Is pregnant or lactating/breastfeeding at time of screening.
* Use of sleep aid medications (such as melatonin, Ambien, Lunestra) or other medications or substances that could affect sleep (alcohol, cannabinoids, or opioids) on nights of in-clinic and at-home recordings.
* Currently enrolled in another clinical study involving an in…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Agreement between Participants with the Same Results in Sleep Staging Using EEG and Sleep Study
Timeframe: Night 1, Night 2
Trial details
NCT IDNCT07485153
SponsorEli Lilly and Company
Sponsor typeINDUSTRY
Study typeOBSERVATIONAL
Primary completion2026-09
Contact for this trial
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or